A Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Multiple Oral Doses Of PF-04895162

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01691274
First received: September 19, 2012
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

The purpose of this study in healthy people is to investigate safety, toleration and time course of plasma concentration of PF-04895162, following multiple oral doses for 14 days. The preliminary effect of food on Pharmacokinetics (PK) after single oral dose of PF-04895162 will also be investigated.


Condition Intervention Phase
Healthy
Drug: PF-04895162
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Parallel Group Dose Escalation Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of Pf-04895162 In Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Maximum observed plasma concentration (Cmax) [ Time Frame: up to 12 h post dose for Days 1, 7 and 14 ] [ Designated as safety issue: No ]
  • Time of maximum concentration (Tmax) [ Time Frame: up to 12 h post dose for Days 1, 7 and 14 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration time profile from time zero extrapolated to inifinite time (AUCinf) [ Time Frame: up to 12 h post dose for Days 1, 7 and 14 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration time profile from time zero to the time of last quantifiable concentration (AUClast) [ Time Frame: up to 12 h post dose for Days 1, 7 and 14 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration time profile from time zero to quantifiable concentration 24 h post dose (AUC24) [ Time Frame: up to 12 h post dose for Days 1, 7 and 14 ] [ Designated as safety issue: No ]
  • AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL) [ Time Frame: up to 12 h post dose for Days 1, 7 and 14 ] [ Designated as safety issue: No ]
  • t1/2 = Terminal Elimination half life [ Time Frame: up to 12 h post dose for Days 1, 7 and 14 ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: October 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04895162 Drug: PF-04895162
Tablets, 300 mg, single, 1 day
Drug: PF-04895162
Tablets, 300 mg, twice a day, 14 days
Drug: PF-04895162
Tablets, to be decided, twice a day, 14 days
Placebo Comparator: Placebo Drug: Placebo
Tablets, twice a day, 14 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male and/or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
  2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  3. An informed consent document signed and dated by the subject.
  4. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives preceding the first dose of study medication.
  • Screening supine blood pressure >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), on a single measurement (confirmed per local SOP) .
  • 12 lead ECG demonstrating QTc >450 or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of <=1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
  • Herbal supplements and hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs and postcoital contraceptive methods) and hormone replacement therapy must be discontinued at least 28 days prior to the first dose of study medication.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • History of seizure or of a condition with risk of seizures. (A history of 1 febrile seizure in childhood does not exclude the subject.)
  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691274

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01691274     History of Changes
Other Study ID Numbers: B5311002
Study First Received: September 19, 2012
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Epilepsy
Phase 1
Multiple Dose
Safety
Pharmacokinetics
Toleration

ClinicalTrials.gov processed this record on July 23, 2014